Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 12:01 AM
NCT ID:
NCT04530058
Eligibility Criteria:
Inclusion Criteria:
1. Aged 60 - 99 years of age.
2. ≥5% total body surface area (TBSA) burn.
3. Admitted to burn center ≤ 120 hours post-burn injury.
4. At least one surgical intervention likely required.
5. Provide written informed consent.
Exclusion Criteria:
1. Death upon admission.
2. Decision not to treat due to burn injury severity.
3. Presence of anoxic brain injury that is not expected to result in complete recovery.
4. Pre-existing renal failure (eGFR is \< 30 mL/min).
5. Severe liver disease (Child-Pugh C).
6. Pre-existing insulin-dependent type II diabetes.
7. Clinical contraindication to give metformin.
8. Allergy to metformin or insulin.
9. History of lactic acidosis while receiving metformin treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
99 Years
Study:
NCT04530058
Study Brief:
Protocol Section:
NCT04530058